Sensors, technology open the door to new era for clinical trials

A woman enrolled in a clinical trial for GlaxoSmithKline's investigational Ebola vaccines receives a dose of the drug. Photo credit: NIAID/Creative Commons

By some estimates it costs a million dollars per month to perform the average clinical study. And that number is increasing roughly 5% to 7% over inflation every year. One big line item is labor. During most trials, highly trained, well-compensated individuals spend an enormous amount of time doing what essentially amounts to paper-based data entry. They manually fill out multipart case report forms, which are then collected centrally, entered into a database, and eventually analyzed.

Another major expense is patient screening and recruitment. One study found that patient-recruitment and -retention difficulties account for up to 45% of all study delays. Another estimated that 25% of all oncology studies nationwide are abandoned before their conclusion for failing to retain a sufficient number of patients. Yet it's estimated that fewer than 10% of cancer patients actually participate in clinical trials, mostly due to logistical complications.

Still, relief is in sight. Of the many advantages offered by leveraging mobile technology for use in clinical trials, efficiencies in labor and patient recruit­ment are the most tangible and within reach.

“It speeds up discovery while at the same time it brings down costs,” says Dr. Noah Craft, CEO and cofounder of Science 37. “So you can do precision oncology research in a way that has never been done before because finding those rare patients across 50 states doesn't require 200 study sites the way it once did. Using our approach, you are essentially decentralizing the patients and the investigators.”

Potential participants can discover trials through Google and Facebook ads, social media posts, and display ads. Science 37 also works with nonprofits, patient-advocacy groups, and health-related blogs as well as online physician networks. Interested individuals can complete the enrollment process via smartphone. They immediately receive a confirmation email and, in most cases, a follow-up phone call within 24 hours.

"The goal is to expand that clinical space so when patients leave the research site they still can be monitored with sensors in their clothes or ingested pills and so on."

These research protocols are new so they aren't without risk — but the time savings to be realized are enormous. Craft estimates that his company can reduce trial time for almost any client by 30% to 50%. And such efficiencies have an even greater impact in crowded fields, where being first to market is essential.

As the pharma industry becomes more globally oriented, expect mobile technologies to play a bigger role in one of the most vexing problems confronting research: obtaining informed consent. Informed consent is a lengthy, confusing, and tedious legal process on a good day. But in locales where language is a barrier, the legacy methods are all but untenable, according to Matthew Howes, SVP at Palio Communications.

SOMETHING BIGGER

“By using digital technology,” Howes explains, “you can take advantage of images and videos and oral communication in a way that cannot be accomplished with a legal document. So you can really make sure patients know exactly what they're getting into.”

Eventually, however, mobile technology will likely move beyond what can be accomplished with devices like smartphones and tablets, according to Howes.

“The goal is to expand that clinical space so when patients leave the research site they still can be monitored with sensors in their clothes or ingested pills and so on,” he continues. “Researchers will be able to monitor how their patients are doing every day rather than just once a month. That sort of sensor technology is the next big turning point for the digitization of mobile clinical trials.”

All this adds up to a more patient-centric approach to clinical trials than in the past, when the focus remained primarily on healthcare providers. In adapting to the changing mind-set, the pharmaceutical companies that flourish will be the ones that behave more like retailers and less like manufacturers, Howes says. Patients will reward brands that “deliver a customer experience,” not just treat them like data points on a graph.

Catherine Geanuracos, formerly Science 37's chief engagement officer, sees a role for marketers in this process.

“In the long run what we're hoping to create is a ­different relationship between individuals and trial participation,” Geanuracos notes. “It's been such a provider-driven conversation up until this point. We want to create a mechanism for patients to fold trial participation into a new way of thinking about their health — that they're contributing to something bigger than themselves.”

Real investment continues to pour into mobile healthcare technology. Globally, it was valued at $10.5 billion in 2014; its compound annual growth rate is projected to be 34% in the 2015–2020 period. By 2017 the market could hit $23 billion, according to forecasters.

However, it's unclear how much of this capital will flow toward the clinical research world. For the most part, the market for mobile tech is predicated not just on selling the devices themselves, but also on retaining proprietary interest in the data that's collected. The maker of that glucose-monitoring sensor in your contact lens, for example, may be reluctant to hand over its data to just any random researcher who comes along.

DATA LEAKAGE

Additionally, assuming that conflicts between capitalism and science can be reconciled, once this deluge of data escapes from academia's ivory tower, data leakage will almost certainly be an issue. At present, no legal protections exist for patients themselves. When your employer learns from your Facebook page that you are being treated for cancer, will your job prospects be impacted negatively? And what might credit agencies do with this information?

Storage space is another problem area. Large healthcare facilities currently have trouble storing already-collected data to say nothing of the vast amounts on the way. However, experts say that this is one area that probably has a relatively easy fix. For the most part, large research players have been reluctant to take advantage of cloud computing, mainly for fear of HIPAA violations. Once they overcome this anxiety, storage should become less of an obstacle.

Whatever form mobile research technology takes, a persistent theme in the industry right now is that it must be driven by the desire to solve clinical problems, not just marketing or sales impulses. Patient engagement is great, but it should be a by-product of solving clinical problems rather than an end unto itself.

As Silicon Valley Data Science's Sanjay Mathur put it in a recent industry white paper: “Companies are so consumed with what technology to use they forget that the most important thing, to start with, is to ask the right questions. You don't need real-time insight if you don't have a place for real-time action.”